CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

NCT ID: NCT05887011

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, non-interventional, study with the aim to access routine practice of diagnostic and treatment approaches in patients with NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The data for all 2000 patients with LA NSCLC and LS-SCLC who receiving CRT will have been collected for 2 years from the primary medical records. Demographic and clinical characteristics of the patients, information of routine diagnostics procedures and treatment approaches for patients with unresectable LA NSCLC and LS-SCLC and the treatment results of the end of CRT will be collected. Information about any specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study. Patients with NSCLC and SCLC meeting the inclusion criteria will be prospectively enrolled into the study. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). Study design considers secondary data collection approach using existing patients' medical records, after patients' visits according to routine sites' practice. Data for visit (record) 1 will be collected at the start of CRT (concurrent or sequential), and data for visit (record) 2 will be collected after the last dose of RT and with CT control results available, but the time frame for this data collection is expected to be no later than 6 months after visit 1.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LA NSCLC

unresectable/inoperable (stage II-III) locally advanced Non-Small Cell Lung Cancer

No interventions assigned to this group

LS-SCLC

unresectable/inoperable Limited-stage small cell lung carcinoma (stage I-III)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years old
2. Provision of written informed consent
3. Patient received at least one RT dose under prescribed CRT (concurrent or sequential) for definitive treatment of locally advanced NSCLC (stage II-III, unresectable or inoperable NSCLC, including locoregional recurrence and patient's refusal to undergo surgery) or LS-SCLC based on local MDT decision
4. Patient is currently undergoing RT (preferably no more than 10 doses)

Exclusion Criteria

1. Participation in another clinical study with an investigational product during the last 3 months
2. Confirmation that the subject was already included in this study before
3. Absence of written informed consent form
4. Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Arkhangelsk, , Russia

Site Status RECRUITING

Research Site

Balashikha, , Russia

Site Status RECRUITING

Research Site

Barnaul, , Russia

Site Status RECRUITING

Research Site

Chelyabinsk, , Russia

Site Status WITHDRAWN

Research Site

Grozny, , Russia

Site Status RECRUITING

Research Site

Irkutsk, , Russia

Site Status RECRUITING

Research Site

Ivanovo, , Russia

Site Status RECRUITING

Research Site

Izhevsk, , Russia

Site Status WITHDRAWN

Research Site

Kaluga, , Russia

Site Status RECRUITING

Research Site

Kazan', , Russia

Site Status RECRUITING

Research Site

Kemerovo, , Russia

Site Status RECRUITING

Research Site

Khabarovsk, , Russia

Site Status RECRUITING

Research Site

Khanty-Mansiysk, , Russia

Site Status RECRUITING

Research Site

Kirov, , Russia

Site Status RECRUITING

Research Site

Kostroma, , Russia

Site Status RECRUITING

Research Site

Krasnodar, , Russia

Site Status RECRUITING

Research Site

Krasnoyarsk, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status WITHDRAWN

Research Site

Nizhny Novgorod, , Russia

Site Status RECRUITING

Research Site

Novokuznetsk, , Russia

Site Status RECRUITING

Research Site

Novosibirsk, , Russia

Site Status RECRUITING

Research Site

Obninsk, , Russia

Site Status RECRUITING

Research Site

Perm, , Russia

Site Status RECRUITING

Research Site

Podolsk, , Russia

Site Status RECRUITING

Research Site

Rostov-on-Don, , Russia

Site Status RECRUITING

Research Site

Ryazan, , Russia

Site Status RECRUITING

Research Site

Saint Petersburg, , Russia

Site Status RECRUITING

Research Site

Saransk, , Russia

Site Status RECRUITING

Research Site

Saratov, , Russia

Site Status RECRUITING

Research Site

Sochi, , Russia

Site Status RECRUITING

Research Site

Syktivkar, , Russia

Site Status WITHDRAWN

Research Site

Tula, , Russia

Site Status RECRUITING

Research Site

Tver', , Russia

Site Status RECRUITING

Research Site

Ulyanovsk, , Russia

Site Status RECRUITING

Research Site

Vladivostok, , Russia

Site Status RECRUITING

Research Site

Vologda, , Russia

Site Status RECRUITING

Research Site

Yakutia, , Russia

Site Status RECRUITING

Research Site

Yaroslavl, , Russia

Site Status RECRUITING

Research Site

Yekaterinburg, , Russia

Site Status RECRUITING

Research Site

Yuzhno-Sakhalinsk, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D133HR00026

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.